PBAC's latest decision on Nirmatrelvir and ritonavir: Recommended with restriction (2023). Considered for Treatment of mild to moderate COVID-19 in patients at high risk of severe disease requiring hospitalisation, including persons aged ≥70 years, immunocompromised persons aged ≥18 years, Aboriginal and Torres Strait Islander persons aged ≥30 years with risk factors, and persons aged 50–69 years with risk factors.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2023
Submissions
1
2023 → 2023
Eligible population
Adults with mild to moderate COVID-19 at high risk of severe disease: (i) persons aged ≥70 years, (ii) persons aged ≥18 years who are moderately to severely immunocompromised or had previously required hospitalisation for COVID-19, (iii) Aboriginal and Torres Strait Islander persons aged ≥30 years with ≥1 risk factor, and (iv) persons aged 50–69 years with ≥1 risk factor.
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
COVID-related hospitalisation or death
Pivotal trial size
2,224 patients
Key trials
EPIC-HR, EPIC-SR
Comparator
placebo (no antiviral medication) and molnupiravir
Economic model
CUA
ICER note
No ICER values stated in the public document; the submission requested maintenance of listing based on cost-effectiveness analysis but specific ICER figures are not provided in the PSD.